Coronary Artery DiseaseNCT07010094
BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
A study testing BM shockwave devices in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd at 1 site in China.
Trial summary
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- BM shockwave devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion criteria:
- Age 18-85 years, male or female;
- Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;
- Patient is able and willing to comply with all assessments in the study.
- Angiography inclusion criteria:
- The target lesion is a de novo, in-situ coronary artery lesion;
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- The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);
- The target lesion diameter stenosis is visually estimated to be ≥70%, or <70% but ≥50% with evidence of ischemia;
- Clear high-density calcification shadows are visible both during cardiac contraction and at rest;
- Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted);
- The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion;
- Patients suitable for treatment with metal stent implantation.
Who cannot join
- General exclusion criteria:
- ST-segment elevation myocardial infarction within 3 days prior to the procedure;
- Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;
- New York Heart Association (NYHA) functional class III or IV;
- Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;
- Uncontrolled severe hypertension (persistent: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg);
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- Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine >2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis;
- Platelet count <60 × 10⁹/L;
- Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;
- Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;
- Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;
- Patients with a life expectancy of less than 12 months due to severe medical conditions;
- Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;
- Pregnant or breastfeeding women;
- Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.
- Contrast exclusion criteria:
- The target lesion and non-target lesion are in the same vascular branch;
- The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;
- A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;
- The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;
- The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft;
- An aneurysm is present within 10 mm of the target lesion;
- Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device;
- The target lesion has definite thrombus formation;
- The investigator determines that the target lesion is not suitable for vascular dilation in the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiamen University Affiliated Cardiovascular Hospital
Fujian, Xiamen, 361000
Wang Yan, Ph.
About this study
Official title: A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- BM shockwave devices
- Keywords
- Coronary artery disease, shockwave therapy, Coronary calcified lesions
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM shockwave devicesDevice
Use the BM shockwave devices for pre-treatment of coronary calcification lesions.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Device: BM shockwave devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success rate
Definition: Residual stenosis ≤30% after PCI, and no major adverse cardiac events (MACE) events occurring during hospitalization. MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.
Measured: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Secondary outcomes (6)
Angiography success rate
Definition: After successful stent placement in the target lesion, residual stenosis ≤ 30%, and no serious angiography complications occur.
Serious angiography complications: refer to the occurrence of D-F type dissection, vascular perforation, acute vascular occlusion, persistent slow blood flow, or no reperfusion during the procedure.
Measured: 0 day
Device success rate
The study device successfully passes through the target lesion, and no serious angiographic complications occur immediately after shockwave pretreatment.
Measured: 0 day
Residual stenosis
Degree of residual stenosis immediately after shockwave pretreatment of the target lesion.
Measured: 0 day
MACE rate
MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.
Measured: 30 days
Target lesion failure
Target lesion failure (TLF) definition: Includes cardiac death, myocardial infarction caused by target vessel (ST-segment elevation or non-ST-segment elevation myocardial infarction), and target lesion revascularization.
Measured: 30 days
Device defects
Incidence of device defects
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start27 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010094
- Sponsor's protocol ID
- D24
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions
- ClinicalTrials.gov ID
- NCT07010094
- Acronym / sponsor ID
- D24
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, shockwave therapy, Coronary calcified lesions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: BM shockwave devices |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- General inclusion criteria:
- The target lesion is a de novo, in-situ coronary artery lesion;
- The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);
- The target lesion diameter stenosis is visually estimated to be ≥70%, or <70% but ≥50% with evidence of ischemia;
- Clear high-density calcification shadows are visible both during cardiac contraction and at rest;
Key exclusion criteria (25 listed)
- General exclusion criteria:
- The target lesion and non-target lesion are in the same vascular branch;
- The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;
- A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;
- The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM shockwave devicesUse the BM shockwave devices for pre-treatment of coronary calcification lesions. | Device | Test group |
Primary outcome
Procedure success rate
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Definition: Residual stenosis ≤30% after PCI, and no major adverse cardiac events (MACE) events occurring during hospitalization. MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.
6 secondary outcomes
Angiography success rate
Time frame: 0 day
Device success rate
Time frame: 0 day
Residual stenosis
Time frame: 0 day
MACE rate
Time frame: 30 days
Target lesion failure
Time frame: 30 days
Device defects
Time frame: 0 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BM shockwave devices in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Yan, Professor (0592-968120, wy@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success rate (time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.